The Prognosis of Early Pregnancy With Post Coital Bleeding

NCT02363569 | Unknown DMC

• 1 other identifier: MeirMc 180-12
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women- E.R." at "Meir" Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy). After they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.

Conditions

Vaginal Bleeding During Pregnancy; Postcoital Bleeding

Keywords

post coital bleeding; vaginal bleeding

Outcome Measures

Primary Outcomes (3)

• Pregnancy Complications (abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension)

  abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension

  after they give birth (8 month after they address to the E.R.)

• Delivery Complications (cesarean section,assisted delivery)

  cesarean section,assisted delivery.

  after they give birth (8 month after they address to the E.R.)

• Newborn Complications (low apgar, small gestational age , need for blood transfusion, artificial respiration, infection)

  low apgar, small gestational age , need for blood transfusion, artificial respiration, infection

  after they give birth (8 month after they address to the E.R.)

Study Arms (2)

case-

Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "Women ER" 24 hours after bleeding or bleeding secretions due to intercourse.

control

Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed the "women ER" due to spontaneous bleeding or bleeding secretions

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with early pregnancy (4-23 weeks) with singletons or twins that address to the "Women E.R." due to vaginal bleeding.

You may qualify if:

• women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the "Women E.R." due to vaginal bleeding.

You may not qualify if:

• age \>40 or \<18
• women with history of more then 3 abortions.
• women with history of more then 2 pre term labor
• ectopic pregnancy
• placental previa
• women who takes anticoagulation therapy
• women with known pathology at cervix.
• women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Hospital

Kfar Saba, Israel, Israel

Location

Related Publications (3)

• Everett C. Incidence and outcome of bleeding before the 20th week of pregnancy: prospective study from general practice. BMJ. 1997 Jul 5;315(7099):32-4. doi: 10.1136/bmj.315.7099.32.

  PMID: 9233324 BACKGROUND

• SPEERT H, GUTTMACHER AF. Frequency and significance of bleeding in early pregnancy. J Am Med Assoc. 1954 Jun 19;155(8):712-5. doi: 10.1001/jama.1954.03690260004002. No abstract available.

  PMID: 13162785 BACKGROUND

• Rosenthal AN, Panoskaltsis T, Smith T, Soutter WP. The frequency of significant pathology in women attending a general gynaecological service for postcoital bleeding. BJOG. 2001 Jan;108(1):103-6. doi: 10.1111/j.1471-0528.2001.00008.x.

  PMID: 11212982 BACKGROUND

MeSH Terms

Conditions

Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meir Pomeranz, M.D

  Meir Hospital, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meir Pomeranz, M.D

CONTACT

+972537482770; Pomeranzmiki@clalit.org.il

Danit Aviv

CONTACT

+97254967060; danith1@walla.co.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 16, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 16, 2015

Record last verified: 2014-12

Locations

IL (1)